13 Oct 2017 | Fujirebio Europe announces CE marking of the Lumipulse® G CK-MB assay, used to aid in the diagnosis of Acute Myocardial Infarction (AMI)

Gent, Belgium: October 13th 2017 – Fujirebio Europe today announced the CE marking of the Lumipulse G CK-MB immunoassay, which can be used as an aid in the diagnosis of Acute Myocardial Infarction (AMI) or as a marker of reinfarction. The launch of this assay now completes1 the Lumipulse G Cardiac panel which also includes BNP, high sensitivity Troponin I and Myoglobin.

“We know that robust assay performance is crucial for clinicians facing the difficult and complex diagnosis of AMI” said Christiaan De Wilde, CEO of Fujirebio Europe. “Building on the robust and reliable Lumipulse G platform, our panel of cardiac assays provide high sensitivity, high precision and a wide dynamic range. These are key factors that ensure you get the right result when time is limited. Added to this, our unique single test cartridge concept helps eliminate reagent waste for cardiac markers such as CK-MB and Myoglobin, assays that will tend to be run in lower volumes.”

About CK-MB

Creatine Kinase (CK) is an enzyme found in high amounts in muscle tissue due to its role in muscle contraction.  CK-MB is found mainly in cardiac muscle, where it comprises 15-40% of the total CK activity, with the remainder being CK-MM.  Trace amounts of CK-MB are found in skeletal muscle (2-3% of the total CK activity); therefore, patients with skeletal muscle injury will have increases in the absolute concentrations of CK and CK-MB. 

Furthermore, release of CK-MB only occurs upon death of myocardial cells and it is not released in the setting of ischemia.  CK-MB was therefore considered to be the most useful biomarker for detection of myocardial injury before the introduction of high sensitivity Troponin assays.

About Fujirebio

Fujirebio is a global leader in the field of high quality in vitro diagnostics (IVD) testing. It has more than 50 years’ accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products.

Founded in 1950 in Tokyo, Japan, Fujirebio has over the years concluded a number of successful acquisitions of best-in-class IVD companies. Examples include Centocor Diagnostics in 1998, CanAg Diagnostics in 2006 and Innogenetics in 2010. Today, Fujirebio’s global presence includes offices in the United States, Latin America, Europe and Asia as well as a vast international distribution network.

Fujirebio has a strong and long-lasting tradition of collaborating with experts in the worldwide clinical community in the development of high-quality routine and truly novel biomarkers that cover a variety of disease states. Its IVD product lines span the range from specialized manual and automated testing to fully automated routine clinical laboratory testing solutions.

Fujirebio is today a member of Miraca Group (Miraca Holdings Inc. listed on the Tokyo Stock Exchange – TYO: 4544) and employs more than 1.200 people in Asia, Europe and America.

References

  1. The Lumipulse G CK-MB assay will be available for shipment as from end October 2017.

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